Applicator instruments for the delivery, deployment, and tamponade of hemostats and methods therefor

ABSTRACT

An instrument used for the delivery, deployment, and tamponade of a hemostat such as a topically applied hemostat includes an intermediate shaft having a proximal end, a distal end, and a central lumen extending to the distal end, and an inner shaft telescopically received within the central lumen of the intermediate shaft, the inner shaft having a proximal end and a distal end that extends distally from the intermediate shaft. The instrument includes an inflatable balloon having a proximal end secured to the intermediate shaft and a distal end secured to the inner shaft, a first actuator for inflating the balloon, and a second actuator for moving the distal ends of the intermediate and inner shafts relative to one another between a first position and a second position for changing the shape of the balloon when the balloon is inflated. The proximal end of the balloon is secured to the distal end of the intermediate shaft and the distal end of the balloon is secured to the distal end of the inner shaft. The balloon has a spherical shape when the intermediate and inner shafts are in the first position and a toroidal shape when the intermediate and inner shafts are in the second position.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is related to commonly assigned U.S. patentapplication Ser. No. ______, entitled “APPLICATOR INSTRUMENTS HAVINGPROTECTIVE CARRIERS FOR HEMOSTATS AND METHODS THEREFOR” (Attorney DocketNo. ETH5373USNP), filed on even date herewith, the disclosure of whichis hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present application is generally related to controlling bleeding,and is more specifically related to systems, instruments, and methodsused for the delivery, deployment, and tamponade of hemostats.

2. Description of the Related Art

Medical textiles are used during surgical procedures to controlbleeding, minimize blood loss, reduce post-surgical complications, andshorten the duration of surgery. Commonly used medical textiles includeadhesion barriers, sponges, meshes, and hemostatic wound dressings thatare applied to the surface of tissue. Hemostatic wound dressings includeabsorbable hemostats such as those sold by Ethicon, Inc. of Somerville,N.J. under the registered trademarks Surgicel®, Surgicel Nu-Knit®, andSurgicel® Fibrillar.

Traditionally, medical textiles have been delivered to surgical sitesusing grasping instruments such as clamps and forceps. It is alsowell-known to use applicator instruments for delivering medicaltextiles. For example, U.S. Pat. No. 3,857,395 discloses an inserterdevice having a pair of outwardly bendable arms that bilaterally spreadan adhesion barrier within a vaginal cavity. The inserter devicedisclosed in the '395 patent, however, is not suitable for insertionthrough an endoscopic tube or trocar.

Commonly assigned U.S. Pat. No. 5,395,383 discloses an applicatorinstrument used for applying a sheet of surgical material (i.e. anadhesion barrier) through an endoscopic tube. The applicator instrumentincludes an expandable operating tip that is insertable into anendoscopic tube to enable a surgeon to apply the surgical material totissue inside a body. In one embodiment, the applicator comprises a setof telescoping tubes including an outer delivery tube, an intermediatedeployment tube, and an inner irrigation tube. The expandable operatingtip is mounted at the distal end of the irrigation tube and is connectedto the distal end of the deployment tube. The spreader tip is exposed atthe distal end of the delivery tube by advancing the deployment tube andthe irrigation tube relative to the delivery tube. The spreader tip isexpanded by movement of the deployment tube relative to the irrigationtube to spread the sheet of surgical material over the tissue. A nozzleis provided at the distal end of the irrigation tube for applying afluid, e.g., a saline solution, to the surgical material.

Commonly assigned U.S. Pat. No. 5,397,332 discloses an applicator forapplying a sheet of surgical material, e.g., a surgical mesh, tointernal body tissue. The applicator includes a delivery tube, adeployment tube slidably received within the delivery tube, and a shaftor irrigation tube slidably received within the deployment tube. Anexpandable spreader tip is connected between the distal ends of theshaft and the deployment tube. The spreader tip is collapsed andinserted in the delivery tube with the surgical mesh. The applicator isinserted through a trocar tube into a body cavity and the spreader tipis exposed by retracting the delivery tube relative to the deploymenttube and shaft. The applicator has a first actuator for urging thespreader tip and surgical mesh into engagement with the tissue as thedeployment tube is retracted, and a second actuator for advancing thedeployment tube relative to the shaft to expand the spreader tip toapply the surgical mesh to the tissue. The spreader tip includes aplurality of flexible strips each having opposite ends pivotallyconnected to the distal ends of the shaft and the deployment tube. Theapplicator includes a return spring to bias the deployment tubeproximally relative to the shaft to normally maintain the spreader tipin a collapsed configuration.

In spite of the above advances, there remains a need for improvedinstruments and methods for the delivery, accurate placement,deployment, and tamponade of medical textiles such as adhesion barriers,wound dressings, and topically applied hemostats. More particularly,there remains a need for applicator instruments that are insertablethrough an endoscopic tube and that are capable of spreading medicaltextiles over a tissue application area to minimize the need formanipulation of the medical textiles by separate grasping instruments.

In addition, there remains a need for instruments and methods for thedelivery, deployment, and tamponade of medical textiles havingmoisture-sensitive components (e.g. moisture-sensitive adhesives), whichmay become ineffective when exposed to fluids or moisture beforereaching a target tissue site.

Moreover, there also remains a need for applicator instruments andmethods for the delivery, deployment, and tamponade of medical textileshaving loosely bound additives such as thrombin and fibrinogen that maybecome dislodged before the medical textiles are placed in contact withthe target tissue.

SUMMARY OF THE INVENTION

In one embodiment, the present invention discloses an applicatorinstrument used for the endoscopic delivery of medical textiles such asmeshes, hemostats, adhesion prevention barriers, and sponges. In oneembodiment, the applicator instrument is preferably adapted for theendoscopic delivery, deployment and tamponade of hemostats such astopically applied hemostats (TAH). The applicator instrument desirablyprotects the topically applied hemostat from exposure to fluids andmoisture until the hemostat is delivered and deployed onto the targettissue. In the present application, the terms “hemostat” and “topicallyapplied hemostat” are used most frequently to describe the variousmedical textiles that may be delivered and deployed by the presentinvention. However, the present application contemplates that theseterms should be read broadly to cover all of the medical textilesdescribed, as well as other materials conventionally used to controlbleeding.

In one embodiment, the applicator instrument includes a balloon that isused to endoscopically deploy and tamponade a hemostat. The deflatedballoon is desirably attached at each end to one of two pieces ofconcentric tubing such that one balloon end is movable and the shape ofthe inflated balloon is changeable from a rounder shape to a flattershape, such as from a spherical shape to a toroidal shape. In oneembodiment, the distal end of the balloon is inverted and the invertedsurface is attached to the outer surface of one of the concentric tubesso that when the balloon is inflated the attachment of the distal end ofthe balloon to the distal end of the device is located inside theinflated balloon. This configuration provides a flatter surface area ofthe balloon for applying an evenly distributed tamponade pressure to thehemostat.

In one embodiment, a cartridge with a breakable or traversable seal at adistal end thereof protects the hemostat from moisture until thehemostat is applied to tissue. Barbed or Velcro®-like hooks may beincorporated at the distal end of the applicator instrument, and thehooks or barbs may be used to pick up the hemostat for loading thehemostat into the tubular cartridge. In other embodiments (e.g. whereprotection from moisture is not needed), the cartridge may not be usedand the hooks hold the hemostat at the distal tip of the instrument asthe instrument is passed through an endoscope or trocar to a surgicalsite. In one embodiment, a system for the delivery, deployment, andtamponade of hemostats may include an applicator device, a plurality ofcartridges, and a stand or cartridge loader for aligning and loading thehemostats into the cartridges.

In one embodiment of the present invention, an instrument forcontrolling bleeding includes an intermediate shaft having a proximalend, a distal end, and a central lumen extending to the distal endthereof, and an inner shaft telescopically received within the centrallumen of the intermediate shaft, the inner shaft having a proximal endand a distal end that extends distally from the intermediate shaft. Theinstrument preferably includes a balloon having a proximal end securedto the intermediate shaft and a distal end secured to the inner shaft, afirst actuator for inflating the balloon, and a second actuator formoving the distal ends of the intermediate and inner shafts relative toone another for changing the shape of the inflated balloon. In oneembodiment, the proximal end of the balloon is secured to the distal endof the intermediate shaft and the distal end of the balloon is securedto the distal end of the inner shaft. The distal end of the balloon maybe inverted and the inverted surface of the balloon may be secured tothe outer surface of the inner shaft at the distal end of the innershaft.

The intermediate and inner shafts may be moved relative to one anotherfor changing the shape of the inflated balloon. In one embodiment, theballoon has a rounder or spherical shape when the intermediate and innershafts are in a first position and a flatter or toroidal shape when theintermediate and inner shafts are in a second position. In oneembodiment, the balloon assumes a toroidal shape, and the flattenedleading face of the balloon is used to apply tamponade pressure to oneor more hemostats.

In one embodiment, the applicator instrument includes an outer shafthaving a proximal end, a distal end, and a central lumen extending tothe distal end of the outer shaft. The intermediate and inner shafts arepreferably disposed within the central lumen of the outer shaft. Theintermediate shaft desirably extends distally from the distal end of theouter shaft and is adapted to slide telescopically relative to the outershaft. In one embodiment, the applicator instrument may include a thirdactuator coupled with the outer shaft for moving the distal end of theouter shaft proximally relative to the distal ends of the intermediateand inner shafts for the purpose of retracting/moving an attachedcartridge connector and cartridge assembly as described in more detailbelow.

In one embodiment, the outer shaft has structure such as a cartridgeconnector provided at a distal end thereof that is adapted to beconnected to a cartridge. The cartridge connector desirably has a grooveor ridge that is adapted to form a detachable coupling or snap-fitconnection with a cartridge. When an actuator coupled with the outershaft is engaged, the outer shaft and the cartridge connected therewithmove toward the proximal end of the instrument. In one embodiment, asthe cartridge moves proximally, a hemostat is delivered through afluid-resistant seal provided at a distal end of the cartridge.

The applicator instrument may include a hemostat disposed at the distalend of the inner shaft. The hemostat may be a medical textile, atopically applied adhesive, a hemostat patch folded over the distal endof the inner shaft, or any conventional medical device used to controlbleeding. The inner shaft may have barbs or hooks provided at the distalend thereof for attaching the hemostat to the inner shaft. Afluid-resistant element may cover the hemostat and be connected to thedistal end of the outer shaft. The fluid-resistant element may include aseal that may be broken for enabling the hemostat to pass through theseal. In one embodiment, the fluid-resistant element is a cartridgeincluding a cartridge tube having an opening at a proximal end of thetube and a fluid-resistant seal at a distal end of the tube. Thehemostat preferably remains in a fluid-resistant compartment defined bythe cartridge until the fluid-resistant seal is broken and the hemostatpasses through the broken seal.

In another embodiment of the present invention, an instrument forcontrolling bleeding includes an outer shaft having a proximal end, adistal end, and a central lumen extending to the distal end thereof, anintermediate shaft telescopically received within the central lumen ofthe outer shaft, the intermediate shaft having a proximal end, a distalend that extends distally from the distal end of the outer shaft, and acentral lumen extending to the distal end thereof. The instrumentdesirably includes an inner shaft telescopically received within thecentral lumen of the intermediate shaft, the inner shaft having aproximal end and a distal end that extends distally from theintermediate shaft. The instrument desirably includes an inflatableballoon having a proximal end secured to the distal end of theintermediate shaft and a distal end that is inverted and secured to thedistal end of the inner shaft. A fluid inlet is desirably locatedbetween the proximal and distal ends of the balloon for selectivelyinflating the balloon. A medical textile such as a hemostat ispreferably disposed at the distal end of the inner shaft. The instrumentdesirably includes at least one actuator for selectively moving thedistal ends of the intermediate and inner shafts relative to one anotherfor changing the shape of the balloon. In one embodiment, the shape ofan inflated balloon may be changed from a generally spherical shape to agenerally toroidal shape.

In one embodiment, a fluid-resistant element may cover the hemostat andbe connected with the distal end of the outer shaft. The fluid-resistantelement desirably comprises a breakable, fluid-resistant seal throughwhich the hemostat may pass for being delivered and deployed at asurgical site.

In one embodiment, the instrument includes a first actuator coupled withthe outer shaft for selectively moving the outer shaft proximallyrelative to the distal ends of the intermediate and inner shafts, asecond actuator for selectively inflating the balloon, and a thirdactuator coupled with at least one of the intermediate and inner shaftsfor selectively moving the distal ends of the intermediate and innershafts relative to one another for changing the shape of an inflatedballoon. In one embodiment, the intermediate and inner shafts desirablyhave tubular shapes, and at least one of the intermediate and innershafts has an opening for introducing fluid, such as air, into theballoon.

In one embodiment of the present invention, an instrument forcontrolling bleeding includes an outer shaft having a proximal end and adistal end, a balloon disposed at the distal end of the outer shaft, amedical textile such as a hemostat disposed adjacent the balloon, anactuator for inflating the balloon, and another actuator for changingthe shape of the inflated balloon. The outer shaft desirably has acentral lumen extending to a distal end thereof.

The instrument may also include an intermediate shaft telescopicallyreceived within the central lumen of the outer shaft, the intermediateshaft having a proximal end, a distal end that extends distally from thedistal end of the outer shaft, and a central lumen extending to thedistal end thereof. The instrument also preferably includes an innershaft telescopically received within the central lumen of theintermediate shaft, the inner shaft having a proximal end and a distalend that extends distally from the intermediate shaft, and the balloonhaving a proximal end secured to the distal end of the intermediateshaft and a distal end secured to the distal end of the inner shaft.

In one embodiment of the present invention, a method for controllingbleeding includes providing an applicator instrument, a hemostat such asa topically applied textile, a cartridge for holding the hemostat, and acartridge loader for facilitating loading the hemostat into thecartridge and attaching the loaded cartridge to a distal end of theapplicator instrument. In one embodiment, a cartridge loader ispositioned atop a support surface and a cartridge is loaded into thecartridge loader. A hemostat such as a hemostatic patch may be placedatop an opening at a proximal or upper end of the cartridge loader. Asthe hemostatic patch is placed atop the cartridge loader, it is alsocentered over an opening at the proximal end of the cartridge. Thedistal tip of the applicator instrument may be abutted against thehemostatic patch for pushing the hemostatic patch into the cartridge. Inone embodiment, the hemostat may have one surface treated with acomponent, and the treated surface may be oriented face up or face downas needed. As the distal tip is advanced into the cartridge, thehemostatic patch may wrap or fold around the distal tip. In oneembodiment, the applicator tip is fully inserted into the cartridgeuntil a snap-fit connection is formed between the cartridge and the tipof the applicator instrument. After the cartridge is connected to thetip of the applicator instrument, the tip of the applicator instrumentand the cartridge may be removed from the central opening of thecartridge loader.

The applicator instrument, with the hemostatic patch and cartridgeconnected thereto, may be advanced to a surgical site such as by passingthe cartridge and the tip of the applicator instrument through anendoscope or trocar. In one embodiment, the distal end of the cartridgeincludes a fluid-resistant seal such as a breakable seal including arubber tip. The seal of the cartridge is advanced until the seal abutsagainst the target tissue at a surgical site. An actuator such as atrigger may be pulled to move the cartridge towards the proximal end ofthe applicator instrument. As the cartridge moves towards the proximalend, the hemostatic patch pierces through the fluid-resistant seal atthe distal end of the cartridge so that the patch may be deliveredagainst the tissue surface. In one embodiment, the applicator instrumentincludes a trigger lock. When the trigger lock is in a locked position,the trigger may not be pulled for delivering the hemostatic patchthrough the fluid-resistant seal. When the trigger lock is in anunlocked position, the trigger may be pulled for delivering the hemostatfrom the cartridge.

After the hemostatic patch has been delivered to the surgical site, aballoon at the distal end of the applicator instrument may be inflatedby engaging an actuator such as a syringe plunger. As the balloon isinflated, the expanding balloon deploys the hemostatic patch byunfurling the hemostatic patch and advancing the edges of the hemostaticpatch toward the tissue surface at the surgical site. When the balloonis inflated, it normally assumes a substantially spherical shape. Theshape of the balloon may be changed, however, by engaging anotheractuator such as a deformation slider that changes the shape of theballoon into a substantially toroidal shape. In the toroidal shape, aleading face of the balloon now assumes a substantially flatter surfacethat provides more surface area for engaging the delivered and deployedhemostatic patch. In one embodiment, tamponade pressure is applied bythe balloon to the hemostatic patch for approximately 1-5 minutes, andmore preferably 2-3 minutes.

In one embodiment, the inflatable balloon is transparent so that thedeployment and tamponade of the hemostat may be observed through theballoon. If bleeding has not been controlled after a predeterminedperiod of time, this condition may be observed through the transparentballoon. In response to this condition, tamponade pressure may beapplied for longer time periods until the bleeding has stopped or isunder control.

In one embodiment, after the bleeding is under control, the deformationslider may be retracted for returning the intermediate and inner shaftsto the normal spacing configuration. As the deformation slider isretracted, the balloon is preferably transformed from a toroidal shapeback to the original spherical shape. The inflated balloon may bedeflated by engaging a syringe plunger locking ring that releases theplunger for deflating the balloon. A spring provided inside the syringemay return the plunger to the retracted position. After the balloon isdeflated, the tip of the applicator instrument may be retracted from thesurgical site and removed from the endoscope or trocar. After theapplicator instrument is withdrawn from the surgical site, the hemostatpreferably remains in place atop the tissue at the surgical site forcontrolling bleeding.

Although the present invention is not limited by any particular theoryof operation, it is believed that the present invention providesnumerous benefits over prior art instruments, systems, and methods. Oneadvantage of the present invention is that the instrument protectshemostats that include moisture-sensitive components from prematureexposure to moisture or fluids (e.g. bodily fluids). This may beaccomplished using a fluid-resistant element that surrounds the hemostatuntil the hemostat is delivered to the tissue surface at a surgicalsite.

In one embodiment, an instrument for delivering a hemostat, such as atopically applied hemostat, includes an outer shaft having a proximalend and a distal end, a hemostat disposed at the distal end of the outershaft, and a fluid-resistant element connected to the distal end of theouter shaft and surrounding the hemostat, whereby the fluid-resistantelement has a breakable, fluid-resistant seal at a distal end thereof.The fluid-resistant element may be snap-fit onto the distal end of theouter shaft. The breakable, fluid-resistant seal may be a pierceablemembrane, a rubber seal, or a cross-slit (four-way duckbill) valve. Thefluid-resistant element may include a cartridge having a breakable,fluid-resistant seal at a distal end thereof. The cartridge may includea cartridge tube having a proximal end, a distal end, and a centralopening extending between the proximal and distal ends thereof. Thecartridge may also include the breakable, fluid-resistant seal coveringthe central opening at the distal end of the cartridge tube. In oneembodiment, the cartridge tube has structure for connecting to thedistal end of the outer shaft. The connecting structure may include oneor more ridges, projections, bumps, grooves, depressions, a press-fit,and/or threads.

The instrument may also include the outer shaft having a central lumenextending to the distal end thereof, an intermediate shafttelescopically received within the central lumen of the outer shaft, theintermediate shaft having a proximal end, a distal end that extendsdistally from the distal end of the outer shaft, and a central lumenextending to the distal end thereof, and an inner shaft telescopicallyreceived within the central lumen of the intermediate shaft, the innershaft having a proximal end and a distal end that extends distally fromthe intermediate shaft. The instrument may also include a balloon havinga proximal end secured to the distal end of the intermediate shaft and adistal end secured to the distal end of the inner shaft, whereby thehemostat is disposed at the distal end of the inner shaft and thefluid-resistant element is connected to the distal end of the outershaft and surrounds the hemostat for forming a fluid-resistant chamberaround the hemostat.

In one embodiment, the instrument includes a first actuator coupled withthe outer shaft for selectively moving the distal end of the outer shaftand the fluid-resistant element proximally for breaking thefluid-resistant seal and delivering the hemostat from the distal end ofthe instrument. The instrument may also include a second actuator forinflating the balloon, and a third actuator for moving the distal endsof the intermediate and inner shafts relative to one another forchanging the shape of the inflated balloon.

In one embodiment, the instrument includes a cartridge loader having anupper end with a platform, and a central opening extending from theplatform toward a lower end of the cartridge loader, whereby the centralopening is adapted to receive the cartridge and the cartridge platformis adapted to receive a hemostat prior to loading the hemostat into thecartridge. The central opening of the cartridge loader desirably has aclosed end with a support surface that conforms to the fluid-resistantseal at the distal end of the cartridge.

In one embodiment, an instrument for controlling bleeding includes anouter shaft having a proximal end, a distal end, and a central lumenextending to the distal end thereof, an intermediate shafttelescopically received within the central lumen of the outer shaft, theintermediate shaft having a proximal end, a distal end, and a centrallumen extending to the distal end thereof, and an inner shafttelescopically received within the central lumen of the intermediateshaft, the inner shaft having a proximal end and a distal end thatextends distally from the intermediate shaft. The instrument alsodesirably includes a hemostat disposed at the distal end of the innershaft, and a water-resistant element connected to the distal end of theouter shaft and surrounding the hemostat, whereby the water-resistantelement has a breakable, water-resistant seal at a distal end thereof.

In one embodiment, an instrument for controlling bleeding includes anouter shaft having a proximal end and a distal end, a balloon disposedat the distal end of the outer shaft, a hemostat disposed adjacent toballoon, and a fluid-resistant element secured to the distal end of theouter shaft and surrounding the hemostat to form a fluid-resistantcompartment around the hemostat, whereby the fluid-resistant element hasa breakable, fluid-resistant seal at a distal end thereof.

In one embodiment, a protective enclosure surrounds the hemostats duringthe delivery of the hemostats to a surgical site to prevent excessiveloss of loosely attached components disposed on hemostats before thedeployment of the hemostats to target tissue. This feature isparticularly important for hemostats having critical and/or costlycomponents such as human thrombin or fibrinogen.

The present invention also enables the shape of an inflated balloon tobe altered so as to maximize the surface area available for applyingtamponade pressure to a deployed hemostat. The increased surface areaand the flatter surface area allows for more efficient and enhancedtamponade pressure to be applied to the hemostats. This feature isparticularly useful for applying pressure to topically appliedhemostats.

In addition, in one embodiment, the present invention discloses anapplicator instrument having a transparent balloon that enables medicalpersonnel to observe a surgical site as tamponade pressure is applied tohemostats using the balloon.

In one embodiment, the intermediate shaft of the applicator instrumentis not moveable, and the balloon does not change shape. After theballoon is inflated to a desired shape, either spherical or toroidal asdescribed earlier, the fluid used to inflate the balloon is communicatedbetween the outer diameter (OD) of the inner shaft and the innerdiameter (ID) of the intermediate shaft. There is desirably no side holein the inner shaft as described in other embodiments, and there is nodistal end plug in the lumen of the inner shaft. The lumen of the innershaft may be in communication through the proximal handle of the device.The proximal end of the inner shaft may have a syringe connector means,such as a Luer connector, attached thereto. The Luer connector may beused to attach a syringe that dispenses a fluid (e.g. SURGIFLO) throughthe lumen of the inner shaft into a surgical cavity, with the balloon ineither an inflated or deflated state. The lumen of the inner shaft mayalso be used to guide, support and allow passage of other fluid deliverysystems, such as the EVICEL Fibrin Sealant having a 45 cm catheterdelivery device. Moreover, a Luer cap or plug may be attached to theLuer connector to prevent surgical cavity insufflation gases fromundesirably exiting through the instrument. In one embodiment, a styletmay be attached to and through the Luer, the length of the stylet beingsuch that its tip is in close proximity to the distal end of the lumenof the inner shaft. The distal tip of the stylet may have Velcro-likebarbs, for the purpose of engaging and picking up and a textile basedtopically applied hemostat (TAH) as described herein in the presentapplication.

In one embodiment, the applicator instrument may not have theintermediate shaft and its related features, and the balloon may notchange shape after it is inflated to have either a spherical or toroidalshape as described earlier. In one embodiment, both the distal andproximal ends of the balloon are attached to the outer diameter (OD) ofthe inner shaft, in the manner as described earlier.

These and other preferred embodiments of the present invention will bedescribed in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a right side elevational view of an instrument for thedelivery, deployment, and tamponade of hemostats, in accordance with oneembodiment of the present invention.

FIG. 2 shows a left side elevational view of the instrument shown inFIG. 1.

FIG. 3 shows a right side elevational view of a proximal end of theinstrument shown in FIG. 1.

FIG. 4 shows a left side elevational view of the proximal end of theinstrument shown in FIG. 2.

FIG. 5 shows a cross-sectional view of the proximal end of theinstrument shown in FIG. 4.

FIGS. 6A and 6B show cross-sectional views of a distal end of theinstrument shown in FIGS. 1 and 2.

FIGS. 7A and 7A-1 show respective front elevational and cross-sectionalviews of the distal end of the instrument shown in FIGS. 1 and 2 with aballoon in an inflated state.

FIGS. 7B and 7B-1 show respective front elevational and cross-sectionalviews of the distal end of the instrument shown in FIGS. 7A and 7A-1after the shape of the inflated balloon has been changed.

FIGS. 8A and 8B show cross-sectional views of the distal end of aninstrument for the delivery, deployment, and tamponade of hemostats, inaccordance with one embodiment of the present invention.

FIG. 9A shows the distal end of the instrument shown in FIGS. 8A and 8Bwith a balloon in an inflated state.

FIG. 9B shows the distal end of the instrument shown in FIG. 9A afterthe shape of the inflated balloon has been changed.

FIG. 10A shows a perspective view of a cartridge loader, in accordancewith one embodiment of the present invention.

FIGS. 10B and 10C show cross-sectional views of the cartridge loadershown in FIG. 10A.

FIG. 11 shows a perspective view of a cartridge having a fluid-resistantseal, in accordance with one embodiment of the present invention.

FIG. 12 shows another perspective view of the cartridge shown in FIG.11.

FIG. 13 shows a front elevational view of the cartridge shown in FIGS.11 and 12.

FIG. 14A shows a cross-sectional view of the cartridge shown in FIGS.11-13.

FIG. 14B shows another cross-sectional view of the cartridge shown inFIGS. 11-13.

FIG. 15 shows the cartridge of FIGS. 11-14B being loaded into thecartridge loader of FIG. 9.

FIG. 16 shows cross-sectional views of the cartridge and the cartridgeloader shown in FIG. 15.

FIG. 17A shows a perspective view of the cartridge loader of FIG. 15after the cartridge of FIG. 11 has been loaded therein.

FIG. 17B shows a cross-sectional view of the cartridge loader andcartridge shown in FIG. 17A.

FIGS. 18-25 show a method of loading a hemostat into a cartridge andconnecting a cartridge to a distal end of the instrument shown in FIGS.1 and 2, in accordance with one embodiment of the present invention.

FIG. 26 shows the distal end of the instrument shown in FIGS. 1-2, 6A,and 6B with a hemostat and a cartridge connected to a distal end of theinstrument.

FIGS. 27A-27M show a method for the delivery, deployment and tamponadeof a hemostat, in accordance with one embodiment of the presentinvention.

FIGS. 27G-1 and 27G-2 show other views of the step shown in FIG. 27G.

FIGS. 27I-1 and 27I-2 show other views of the step shown in FIG. 27I.

FIG. 28 shows a system for the delivery, deployment, and tamponade of ahemostat including an applicator instrument, a cartridge, an outer tube,and a trocar, in accordance with one embodiment of the presentinvention.

FIGS. 29A-29C show the cartridge of FIG. 28.

FIGS. 30A and 30B show a distal end of the applicator instrument of FIG.28 being inserted into the outer tube of FIG. 28.

FIGS. 31A-31B show the delivery of a hemostat to a surgical site, inaccordance with one embodiment of the present invention.

FIGS. 32A-32C show a method of advancing a hemostat through afluid-resistant seal of a cartridge, in accordance with one embodimentof the present invention.

DETAILED DESCRIPTION

The invention disclosed herein is not limited in its application or useto the details of construction and arrangement of parts illustrated inthe accompanying drawings and description. The illustrative embodimentsof the invention may be implemented or incorporated in otherembodiments, variations and modifications, and may be practiced orcarried out in various ways.

The headings used herein are for organizational purposes only and arenot meant to limit the scope of the description or the claims. As usedthroughout this application, the word “may” is used in a permissivesense (i.e., meaning having the potential to), rather than the mandatorysense (i.e., meaning must). Similarly, the words “include”, “including”,and “includes” mean including but not limited to. To facilitateunderstanding, like reference numerals have been used, where possible,to designate like elements common to the figures.

Referring to FIGS. 1 and 2, a system for the delivery, deployment, andtamponade of hemostats such as topically applied hemostats includes anapplicator instrument 100 having a proximal end 102 and a distal end104. The instrument 100 includes a handle 106 having a trigger 108 and atrigger lock 110. The trigger 108 is coupled with an outer shaft 112that extends toward the distal end 104 of the instrument 100. Thetrigger 108 may be pulled for moving the outer shaft 112 in a proximaldirection toward the proximal end 102 of the applicator instrument 100.

The instrument 100 also includes a syringe 114 that is used toselectively inflate a balloon 160 desirably located adjacent the distalend 104 of the instrument. The syringe 114 includes a plunger 116 and abarrel 118 that receives the plunger 116. The plunger 116 may be pressedtoward the distal end 104 of the instrument 100 for inflating theballoon. The syringe 114 also includes a plunger locking ring 120 thatdesirably locks the plunger 116 from movement relative to the barrel118. The plunger locking ring 120 may be moved to an unlocked position(e.g. moved toward the distal end 104 of the instrument 100) forenabling the plunger 116 to move relative to the barrel 118. The syringe114 may include an internal spring for returning the plunger 116 to anextended position. In one embodiment, the syringe 114 may include a seal(not shown) that is positioned between the plunger and the barrel tomaintain a pneumatic or hydraulic seal. Referring to FIG. 2, theapplicator instrument 100 also includes a deformation slider 122 thatmay be pressed toward the distal end 104 of the instrument for changingthe shape of the balloon 160 when the balloon is inflated, as will bedescribed in more detail below.

Referring to FIG. 3, the handle 106, located at the proximal end 102 ofthe instrument 100, includes the trigger 108 and the trigger lock 110.In operation, the trigger lock 110 may be moved to an unlocked positionto enable the trigger 108 to be pulled toward the proximal end 102 ofthe instrument 100. The direction that the trigger 108 may be pulled isdesignated A₁ in FIG. 3. In other embodiments, the trigger or anotherform of actuator may be pulled in another direction. A leading end 124of the trigger 108 may be connected to a hollow tube 126 that is adaptedto slide over the plunger barrel 118. The trigger 108 is coupled to theouter shaft 112 via the trigger leading end 124 and the hollow barrel126.

The distal end of the plunger barrel 118 includes a connector 128 thatis coupled with a conduit 130 that is used to direct fluid such as highpressure air into the inflatable balloon (not shown). As will bedescribed in more detail below, the fluid passes through an inner shafthaving an opening located inside the inflatable balloon. As the plunger116 is depressed into the barrel 118, the fluid is directed through theconduit 130 and into the balloon for inflating the balloon. Whendesired, the inflatable balloon may be deflated by enabling the plungerto return to an extended position as shown in FIG. 3. When the plungerlocking ring is in the position shown FIG. 3, the plunger 116 is lockedin place relative to the plunger barrel 118. In order to return theplunger 116 to the extended position, the plunger locking ring 120 maybe moved toward the distal end of the instrument 100. The outer surfaceof the plunger 116 desirably includes ridges 130 that may engage theplunger locking ring 118 for selectively locking the plunger 116 inplace. In one embodiment, the outer surface of the plunger may not haveridges, but may have a smooth or roughened surface that allowsfrictional engagement with the inner diameter of the locking ring.

Referring to FIG. 4, in one embodiment of the present invention, theinstrument 100 includes the deformation slider 122 that may be advancedtoward the distal end of the instrument. The deformation slider 122 iscoupled with a proximal end of an intermediate shaft 132. Theintermediate shaft 132 has a distal end (not shown) that is attached toa proximal end of the inflatable balloon. In a preferred embodiment, theproximal end of the inflatable balloon is attached to the outer surfaceof the intermediate shaft 132 at the distal end of the intermediateshaft 132. An air-tight seal preferably exists between the proximal endof the inflatable balloon and the distal end of the intermediate shaft132.

FIG. 5 shows a cross-sectional view of the proximal end 102 of theinstrument 100. The handle 106 includes the trigger 108 and the triggerlock 110. As noted above, the trigger lock 110 may be moved into anunlocked position for enabling the trigger 108 to be pulled toward theproximal end 102 of the instrument 100. The trigger 108 includes theleading end 124 that is coupled with the hollow tube 126. As the trigger108 is pulled toward the proximal end of the instrument in the directionA₁, the trigger leading end 124 and the hollow tube 126 pull the outershaft 112 toward the proximal end 102 of the instrument 100. Theinstrument 100 includes an O-ring seal 125 that engages the outersurface of the intermediate shaft 132.

In order to inflate the inflatable balloon (not shown), the plunger 116may be pressed toward the distal end of the instrument for compressingthe fluid (e.g. air) located within the plunger barrel 118. Thecompressed fluid is forced into conduit 130 which, in turn, directs thecompressed fluid into an inner shaft 134 for inflating the inflatableballoon. After the plunger 116 has been depressed, plunger locking ring120 engages the ridges 130 on the outside of the plunger 116 for lockingthe plunger 116 in place. The balloon will remain inflated as long asthe plunger is locked in place. In order to deflate the balloon, theplunger locking ring 120 may be pressed toward the distal end of theinstrument 100. After the plunger locking ring 120 is depressed, theplunger locking ring no longer closely engages the ridges 130 on theouter surface of the plunger portion 116, which enables the plunger 116to move toward the proximal end 102 of the instrument 100. As shown inFIG. 5, the syringe desirably includes a spring 135 that returns theplunger 116 to the extended position. As noted above, the balloondeflates as the plunger 116 returns to the extended position.

As will be described in more detail below, the distal end of theinflatable balloon is attached to the distal end of the inner shaft 134.In one preferred embodiment, the distal end of the inflatable balloon isinverted and the inverted surface of the balloon is attached to theouter surface of the inner shaft 134. In addition, the proximal end ofthe inflatable balloon is attached to the outer surface of theintermediate shaft 132. After the balloon has been inflated, theintermediate shaft 132 may be advanced distally relative to the distalend of the inner shaft 134. As the intermediate shaft 132 advancesdistally relative to the inner shaft 134, the shape of the inflatedballoon changes. In one embodiment, the inflated balloon initially has agenerally spherical shape. After the intermediate shaft 132 is advanceddistally, however, the inflated balloon changes shape from a rounder ormore spherical shape to a generally flatter or more toroidal shapehaving a flatter leading surface. The flatter leading surface of theballoon provides a larger surface area for pressing against hemostatssuch as topically applied hemostats, as will be described in more detailbelow.

FIG. 6A shows the distal end 104 of the instrument 100, in accordancewith one embodiment of the present invention. The instrument 100includes the outer shaft 112 having a distal end 140 and a central lumen142 extending from the distal end 140 toward the proximal end of theouter shaft 112. The instrument 100 includes a cartridge connector 144having a proximal end 146 inserted into the central lumen 142 of theouter shaft 112 and a distal end 148 remote therefrom. The distal end148 of the cartridge connector 144 has an annular groove 150 formedtherein. As will be described in more detail below, the annular groove150 is adapted to engage a proximal end of a cartridge for connectingthe cartridge to the distal end 148 of the cartridge connector 144. Theinstrument 100 also includes a cartridge connector O-ring seal 152 thatdesirably forms an air-tight seal between the distal end 148 of thecartridge connector 144 and the outer surface 154 of the intermediateshaft 132. The O-ring seal 152 preferably prevents body or other fluidsfrom entering and contaminating internal portions of the device. TheO-ring seal 152 is desirably held in place by retainer wall 155.

The instrument 100 includes the intermediate shaft 132 that extendsdistally from the distal end 148 of the cartridge connector 144. Theinstrument 100 also includes the inner shaft 134 that extends distallyfrom the intermediate shaft 132. The intermediate shaft 132 preferablyhas an internal lumen extending between proximal and distal ends thereofand the inner shaft 134 telescopically slides within the central lumenof the intermediate shaft 132. The intermediate shaft 132 may beselectively moved relative to the inner shaft 134 (e.g. by pressing thedeformation slider toward the distal end of the instrument). In oneembodiment, the inner shaft 134 includes an opening 156 that is incommunication with the inside of the inflatable balloon 160 forselectively inflating and deflating the balloon.

Referring to FIGS. 6A and 6B, the instrument 100 includes the inflatableballoon 160 having a proximal end 162 attached to the outer surface 154of the intermediate shaft 132 at the distal end of the intermediateshaft. The inflatable balloon 160 also has a distal end 164 that isattached to the outer surface of the inner shaft 134 at the distal endof the inner shaft. The balloon may be made of a wide array of materialsused to make medical balloons including elastomers such as polyurethaneelastomers and silicone elastomers, and polymers. For example, theballoons may include any of the medical balloons sold by Polyzen, Inc.As shown in FIG. 6B, the distal end 164 of the inflatable balloon 160 isinverted and the inverted surface is attached to the outer surface ofthe inner shaft 134. The instrument 100 also includes an inner shaftseal 166 that is inserted into the central lumen of the inner shaft 134at the distal end of the inner shaft.

FIGS. 7A and 7A-1 show how the shape of the inflatable balloon 160 maybe changed. Referring to FIG. 7A, as described above, fluid may bepassed through the opening 156 in the inner shaft 134 for inflating theballoon 160. The proximal end 162 of the balloon 160 is attached to theintermediate shaft 132 and the distal end 164 of the balloon 160 isinverted, with the inverted surface attached to the distal end of theinner shaft 134.

Referring to FIGS. 7B and 7B-1, after the balloon 160 is inflated, theintermediate shaft 132 is moved toward the distal end 104 of theinstrument 100 and relative to the inner shaft 134. As the intermediateshaft 132 is moved distally relative to the inner shaft 134, the shapeof the balloon 160 will change. In one preferred embodiment, theinflatable balloon 160 assumes a toroidal shape having a substantiallyflat leading face 170. Although the present invention is not limited byany particular theory of operation, it is believed that the toroidalshaped balloon 160 and the substantially flat leading face 170 of theballoon provides both a flatter surface area and a larger surface areafor more evenly applying pressure to hemostats such as topically appliedhemostats, as will be described in more detail below.

In one embodiment, the intermediate shaft 132 has an outside diameter ofabout 0.2 inches, and a wall thickness of about 0.01 inches. The innershaft 134 desirably has sufficient clearance to allow it to freely slidewithin the intermediate shaft. The wall thickness of the inner shaft 134is preferably about 0.01 inches. In one embodiment, the distal end ofthe inner shaft 134 projects beyond the distal end of the intermediateshaft 132 by about one inch.

In one embodiment, a cylindrical balloon is attached to the intermediateand inner shafts. The distal end of the balloon is attached or bondedover the distal 0.25 inches of the inner shaft and the proximal end ofthe balloon is attached or bonded over the distal 0.25 inches of theintermediate shaft. The balloon's attachment at its distal end is suchthat the balloon is inverted over itself. When the balloon is inflated,the attachment of the distal end of the balloon to the distal end of theinstrument is located inside the inflated balloon. In one embodiment, aseal is provided at the distal end of the inner shaft. The inner shaftmay include a hole formed in a side wall thereof to allow for inflationand deflation of the balloon.

In one embodiment, a seal, such as an O-ring, may be disposed betweenthe intermediate and inner shafts to prevent leakage when inflating theballoon. The proximal end of the inner shaft may be coupled with adevice, such as a syringe, to inflate and deflate the balloon. Theproximal ends of the intermediate and inner shafts may be containedwithin a housing that provides for easy manual control of the shafts forslidably moving the intermediate shaft forward a distance of up to about0.75 inches. The housing also includes an element for manually inflatingand deflating the balloon. The housing may resemble those of othertrigger-operated endoscopic devices, such as the EES Proximate Staplerline or the Ethicon Morcellex device.

Referring to FIGS. 8A and 8B, in one embodiment, the instrument 100′includes Velcro®-like barbs or hooks 165′ provided at a distal endthereof. As described in more detail herein, the Velcro®-like barbs orhooks 165′ are adapted to engage a hemostat for holding the hemostat atthe distal end of the instrument during delivery and deployment of thehemostat at a surgical site.

In one embodiment, the instrument does not include a cartridge thatholds or covers the hemostat at the distal end of the instrument. Inthis embodiment, the Velcro®-like hooks or barb perform one of thefunctions provided by the cartridge so as to hold the hemostat at thedistal end of the instrument.

FIG. 9A shows the applicator instrument 100′ of FIGS. 8A and 8B afterthe balloon 160′ has been inflated. As shown in FIG. 9A, the leadingface 170′ of the balloon 160′ extends beyond the Velcro®-like hooks orbarbs 165′. In FIG. 9B, the intermediate shaft 132′ has been advanceddistally relative to the inner shaft 134′ so as to change the shape ofthe balloon 160′. As shown in FIG. 9B, the leading face 170′ of theballoon is flatter than the leading face of the balloon of FIG. 9A.

Referring to FIG. 10A, in one embodiment of the present invention, asystem for the delivery, deployment, and tamponade of hemostats includesa cartridge loader 172 having an upper end 174 including a centralopening 176 and a lower end 178 including a support base 180. The upperend 174 of the cartridge loader 172 has a platform 182 that surroundsthe central opening 176. The platform 182 is adapted to receive and holda hemostatic device such as a hemostat patch for loading into acartridge. A ridge 184 desirably extends around an outer perimeter ofthe platform 182 for centering and/or holding the hemostat in place overthe central opening 176.

Referring to FIGS. 10B and 10C, the cartridge loader 172 includes thecentral opening 176 that extends between the upper end 174 and the lowerend 178 of the cartridge loader. The central opening 176 has an open endadjacent the platform 182 and a closed end 186 adjacent the base 180.The closed end 186 of the central opening 176 includes a cartridgereceiving surface 188 that is designed to receive and support a leadingend of a cartridge (not shown). In one embodiment, the cartridgereceiving surface 188 includes a pair of projections 190A that areadapted to support the leading end of the cartridge, while minimizingany damage to the seal provided at the leading end of the cartridge. Thecartridge receiving surface 188 also maintains the seal end of acartridge in a closed position as a hemostat is loaded therein, as willbe described in more detail below.

Referring to FIG. 11, in one embodiment of the present invention, thesystem includes a cartridge 192 that is loadable into the cartridgeloader 172 shown above in FIGS. 9-10B. The cartridge 192 preferablyincludes a cartridge tube 194 having a proximal end 196 that is open anda distal end 198 that has a fluid-resistant seal. In one embodiment, thefluid-resistant seal 200 is preferably secured over the distal end 198of the cartridge tube 194. In the embodiment shown in FIG. 11, thefluid-resistant seal is a four-way duck bill valve, although otherconventional fluid-resistant seals may be used. The distal-most end ofthe four-way duck bill valve has a cruciform shape with elongated slitsor openings 205 provided at the distal end of the cruciform-shapedstructure for enabling a hemostatic device to pass therethrough.

Referring to FIG. 12, in one embodiment, the proximal end 196 of thecartridge tube 194 has a central opening 202 that extends from theproximal end 196 toward the distal end 198 thereof. The inner surface204 of the cartridge tube 194 desirably has one or more projections 206extending therefrom. The projections 206 preferably engage the annulargroove 150 provided at the distal end 148 of the cartridge connector 144for enabling the cartridge to form a snap-fit connection with the distalend of the instrument 100 (FIG. 1). The central opening 202 ispreferably sized and shaped to enable a hemostat such as a medicaltextile or a topically applied hemostat to be loaded therein, as will bedescribed in more detail below.

Referring to FIG. 13, the cartridge 192 includes the fluid-resistantvalve 200 secured over the distal end 198 of the cartridge tube 194. Thedistal end of the fluid-resistant valve 200 includes one or moredepressions 208 adapted to sit atop the projections 190A, 190B providedat the closed end 186 of the central opening 176 of the cartridge loader172 (FIG. 10B). Referring to FIGS. 10B and 13, the apexes of theprojections 190A, 190B preferably abut against the distal-most end 198of the cartridge tube 194 for supporting the cartridge tube 194 withinthe central opening 176, without damaging the fluid-resistant valve.

Referring to FIGS. 14A and 14B, in one embodiment the cartridge tube 194has a distal end 198 and the fluid-resistant seal 200 is secured overthe distal end thereof. The seal 200 includes elongated openings orslits 205 that may be opened to enable a hemostat to pass therethrough.The cartridge tube 194 includes the central opening 202 that desirablyextends from the proximal end 196 to the distal end 198 of the cartridgetube 194. The inner surface 204 of the cartridge tube 198 includes aseries of projections 206 that enable the proximal end 196 of thecartridge tube 194 to be snap-fit connected to a cartridge connector(FIGS. 6A and 6B) located at the distal end of the instrument.

In one embodiment, the cartridge tube is a cylinder with an outerdiameter of about 0.2-0.5 inches, and more preferably about 0.394 inches(10 mm), a wall thickness of about 0.02 inches, and a length of about1.5 inches. In other embodiments, the dimensions indicated above mayvary and still fall within the scope of the present invention. Thedistal end of the cartridge desirably has a pierceable, punctureable, ortraversable seal. The proximal end of the cartridge tube may be open andmay have a beveled edge resembling a funnel-like feature.

In one embodiment, the outer shaft of the instrument has an outerdiameter of about 0.2-0.5 inches, and more preferably about 0.394 inches(10 mm) and a wall thickness of about 0.02 inches. The outer shaft ispreferably positioned concentrically about the intermediate and innershafts of the applicator instrument. The distal end of the outer shaftdesirably has an element for concentrically engaging and securing theproximal end of the cartridge. In one embodiment, the distal end of theouter shaft is normally positioned about 1.5 inches proximal to thedistal tip of the inner shaft. The outer shaft is adapted to slideaxially toward the proximal end of the instrument.

The distal tip of the inner shaft may have barbed or Velcro®-like hooksthat protrude distally. The barbs or hooks may be used to pick up thehemostat for loading the hemostat into a cartridge. In one embodiment,the length of the outer shaft (the “working length”) is about 10-15inches, and more preferably about 13 inches (33 cm).

Referring to FIGS. 15 and 16, in one embodiment of the presentinvention, the cartridge 192 is preferably loaded into the cartridgeloader 172 by aligning the fluid-resistant seal 200 at the lower end ofthe cartridge tube 194 with the central opening 176 of the cartridgeloader 172. The cartridge 192 may then be slid into the central openinguntil the lower end of the cartridge engages the cartridge supportingsurfaces 188 (FIG. 1A).

FIGS. 17A and 17B show the cartridge loader 172 after the cartridge 192has been loaded into the central opening 176. Referring to FIG. 17B, thefluid-resistant seal 200 at the lower end of the cartridge 192 desirablyengages the cartridge supporting projections (not shown) provided at theclosed end 186 of the central opening. As described above, theprojections preferably support the distal end of the cartridge tube 194,while minimizing the likelihood of damage to the fluid-resistant seal200.

Referring to FIG. 18, in one embodiment of the present invention, afterthe cartridge 192 is positioned within the cartridge loader 172, ahemostat such as a hemostat patch 210 is placed atop the patchsupporting platform 182 and within the ridge 184 surrounding the outerperiphery of the platform 182. The hemostat patch is preferably centeredover the central opening 176 provided at the top of the cartridge loader172.

FIGS. 19A and 19B show the hemostat patch 210 positioned atop theplatform 182 of the cartridge loader 172. As shown in FIG. 19B, thehemostat patch 210 overlies the proximal end of the cartridge tube 194and the central opening 176 of the cartridge loader 172.

Referring to FIG. 20, in one embodiment of the present invention, thehemostat patch 210 is loaded onto the distal end of the instrument 100by first aligning the distal end 104 of the instrument 100 with thehemostat patch 210, which in turn is centered atop the cartridge loader.

FIG. 21 shows the distal end 104 of the instrument 100 aligned over thehemostat patch 210 provided atop the cartridge loader 172. Theinstrument 100 includes the outer shaft 112 and the cartridge connector144 secured to the distal end of the outer shaft 112. The distal-mostend of the cartridge connector 144 includes an annular groove 150adapted to engage projections provided at a proximal end of thecartridge (not shown). The instrument 100 includes intermediate shaft132 and inner shaft 134 that extends from the distal-most end of theintermediate shaft 132. The instrument also includes the inflatableballoon 160 having its proximal end secured to the distal end of theintermediate shaft 132 and its distal end secured to the distal end ofthe inner shaft 134.

Referring to FIGS. 22A and 22B, the hemostat patch 210 is forced intothe opening at the proximal end of the cartridge tube 194 by abuttingthe distal-most end of the instrument 100 against the hemostat patch210. As shown in FIG. 22B, the distal-most end of the instrument 100forces the hemostat patch 210 into the cartridge tube 194 and toward thefluid-resistant seal 200 at the distal end of the cartridge 192.

FIGS. 23 and 24 show the instrument 100 after the hemostat patch hasbeen advanced into the cartridge and a snap-fit connection is formedbetween the cartridge 192 and the cartridge connector 144. As shown inFIG. 24, the distal end of the instrument 100 has been advanced to theclosed end 186 of the central opening of the cartridge loader 172. Asthe distal end 104 moves toward the closed end 186 of the centralopening, the hemostat patch 210 is forced into the opening in thecartridge tube 194. The annular groove 150 at the distal end of thecartridge connector 144 preferably forms a snap-fit connection with theprojections 206 adjacent the proximal end of the cartridge tube 194.

Referring to FIG. 25, after the hemostat patch is loaded into thecartridge opening and a snap-fit connection is formed between thecartridge and the cartridge connector 144, the distal end of theinstrument 100 may be removed from the central opening of the cartridgeloader 172.

FIG. 26 shows the distal end 104 of the instrument 100 after thehemostat patch 210 and the cartridge 192 have been loaded onto thedistal end 104 of the instrument. As shown in FIG. 26, the projections206 at the proximal end of the cartridge tube 194 engage the annulargroove 150 at the distal end 148 of the cartridge connector 144. Theballoon 160 is deflated and is located between the hemostat patch 210and the outer surface of inner shaft 134. The fluid-resistant seal 200at the distal-most end of the instrument 100 preferably maintains amoisture-free environment within the cartridge 192 to prevent moistureor fluids (e.g. bodily fluids) from prematurely contacting the hemostatpatch.

In one embodiment, the hemostat patch 210 is delivered from thedistal-most end of the instrument 100 by moving the outer shaft 112toward the proximal end of the instrument 100 in the direction indicatedby axis A₃. As the outer shaft 112 moves toward the proximal end of theinstrument relative to the intermediate shaft 132 and the inner shaft134, the cartridge 192 is pulled over the intermediate shaft 132 and theinner shaft 134 and toward the proximal end of the instrument throughthe snap-fit connection between the cartridge connector 144 and theproximal end of the cartridge. As the cartridge 192 is pulled toward theproximal end of the instrument, the hemostat patch 210 breaches thefluid-resistant seal 200 located at the distal end of the cartridge 192.

FIGS. 27A-27M show a method of delivering, deploying and tamponading ahemostat, in accordance with one embodiment of the present invention.Referring to FIG. 27A, after the hemostat and the cartridge have beenloaded onto the distal end of an applicator instrument as shown in FIG.26, the distal end of the instrument is passed through a trocar tube230. The distal end 232 of the trocar tube 230 is desirably passedthrough an opening in a body, with the distal end 232 aimed towards atarget site 234 on the tissue 236.

Referring to FIG. 27B, the cartridge 192 attached to the distal end ofthe applicator instrument is passed through an opening at the distal end232 of the trocar until the fluid-resistant seal 200 abuts against thetarget site 234 on the tissue 236. The fluid-resistant seal may bepreferably made of a flexible material such as rubber so as to minimizedamage to the tissue. FIG. 27C shows the fluid-resistant seal 200 at thedistal end of the cartridge 192 abutting against the target site 234 onthe tissue 236.

Referring to FIGS. 27D and 27E, the trigger lock 110 may be moved to theunlocked positioned for enabling the trigger 108 to be pulled. As thetrigger 108 is pulled, the outer shaft 112 and the cartridge 192 arepulled toward the proximal end of the instrument in the directionindicated by axis A₃ so as to deliver the hemostat 210 to the targetsite 234 on the tissue 236. As shown in FIG. 27E, the balloon 160provided at the distal end of the instrument 100 remains deflated.

Referring FIGS. 27F and 27G, the syringe plunger 116 is depressed forforcing air into the inner shaft for inflating the balloon 160. In oneembodiment, the balloon 160 is transparent so that the hemostat 210 andthe surgical site may be continuously observed through the inflatedballoon 160.

Referring to FIGS. 27H-27I, the deformation slider 122 may be pressedtoward the distal end of the instrument 100 for changing the shape ofthe inflated balloon 160. As the deformation slider 122 is advanced, thedistal end of the intermediate shaft moves distally relative to thedistal end of the inner shaft. As the intermediate and inner shafts moverelative to one another, the shape of the inflated balloon 160 becomesflatter. In particular, the leading face of the inflated balloon becomesflattened for providing more surface area contact with the hemostat 210.Tamponade pressure is applied by the leading face of the inflatedballoon 160 for a period of time to stop bleeding at the desired tissuelocation. In one embodiment, the inflated balloon 160 is transparent sothat the surgical site may be continuously observed through the balloon.In one embodiment, the tamponade pressure is applied for approximately1-5 minutes, and more preferably approximately 2-3 minutes. In otherembodiments, tamponade pressure is applied until the bleeding is stoppedor is under control.

FIGS. 27G-1 and 27G-2 show other views of the inflated balloon 160 shownin FIG. 27G. Referring to FIG. 27G-1, the distal end of the instrument100 has delivered and deployed the hemostat patch 210 to the desiredsite 236 atop tissue 234. Referring to FIG. 27G-2, the leading face ofthe balloon 160 engages the hemostat patch 210. However, the peripheraledges 215 of the hemostat patch 210 are not engaged by the leading faceof the inflated balloon 160. This may be due, in part, to thesubstantially spherical shape of the balloon shown in FIG. 27G-2.

Referring to FIGS. 27I-1 and 27I-2, in order to flatten the leading faceof the inflated balloon 160, the intermediate shaft 132 is moveddistally relative to the inner shaft 134. As shown in FIG. 27I-2, theproximal end 162 of the balloon is secured to the distal end of theintermediate shaft 132 and the distal end 164 of the balloon 160 issecured to the distal end of the inner shaft 134. Thus, as theintermediate shaft moves distally relative to the inner shaft 132, theshape of the balloon 160 attached to the two shafts will flatten. Asshown in FIG. 27I-2, the leading face of the inflated balloon 160assumes a flatter shape and covers a larger area so as to fully engagethe hemostat patch 210 including the peripheral edges 215 of thehemostat patch.

Referring to FIGS. 27J and 27K, after the tamponade pressure has beenapplied to the hemostat patch for a desired period of time (e.g.sufficient to stop bleeding), the deformation slider 122 may beretracted toward the proximal end of the instrument 100. As thedeformation slider 122 retracts, the intermediate shaft moves proximallyrelative to the inner shaft to return the balloon 160 to thesubstantially spherical shape shown in FIG. 27K.

Referring to FIGS. 27L and 27M, after the balloon 160 is returned to thespherical shape, the balloon may be deflated by engaging the syringeplunger locking ring 120 so as to allow the plunger 116 to moveproximally for releasing fluid from the balloon 160. The deflatedballoon and the distal end of the applicator instrument may then beretracted from the trocar. After the instrument has been retracted, thehemostat patch preferably remains in place atop the tissue for stoppingand/or controlling bleeding, or for other desired functions.

FIG. 28 shows a system for the delivery, deployment, and tamponade of ahemostat, in accordance with one embodiment of the present invention.The system may include one or more of the structural features and/orfunctions of the applicator instrument described above in FIGS. 1-27M.The system desirably includes an applicator instrument 1100 having aproximal end 1102, a distal end 1104, an intermediate shaft 1132, and aninner shaft 1134. The applicator instrument includes an inflatableballoon having one end secured to the intermediate shaft and one endsecure to the inner shaft. The intermediate and inner shafts may bemoved relative to one another for changing the shape of an inflatedballoon. The system includes a cartridge 1192 that is adapted to receivea hemostat 1210. The system also has an outer tube 1112, and a trocar1230.

Referring to FIGS. 29A-29C, the cartridge 1192 for the system includes acartridge tube 1194 having a proximal end 1196, a distal end 1198, acentral opening 1202 extending between the proximal and distal ends, anda fluid-resistant or moisture impermeable seal 1200 covering the centralopening 1202 at the distal end 1198 of the cartridge tube 1194. As shownin FIGS. 29A and 29B, the proximal end 1196 of the cartridge tube 1194has a beveled edge 1215 that guides a hemostat patch into the centralopening 1202 without snagging or damaging the hemostat patch on an edgeof the cartridge.

Referring to FIGS. 30A and 30B, after the hemostat has been loaded intothe cartridge 1192 by the distal tip of the instrument 1100, the loadedcartridge is passed through the outer tube 1112. When the cartridge 1192reaches the distal end 1232 of the outer tube 1112, the distal end 1198of the cartridge 1192 engages a cartridge stop feature 1235 provided atthe distal end 1232 of the outer tube 1112. After the cartridge 1192 hasbeen positioned as shown in FIG. 30B, the fluid-resistant seal 1200 onthe cartridge remains in place for preventing moisture from reaching thehemostat patch 1210 contained within the cartridge 1192.

Referring to FIGS. 31A and 31B, the distal end 1104 of the instrument1100 is advanced to a target location 1234 on tissue 1236 through atrocar tube 1230. The distal tip of the instrument 1100 is then advancedthrough the distal end 1232 of the trocar 1230. Referring to FIG. 31B,as the distal tip 1104 of the instrument 1100 is advanced further, theseal at the distal end of the cartridge 1192 is pierced and the hemostat1210 is delivered to the desired site 1234 on the tissue 1236. A balloonprovided at the distal end 1104 of the instrument 1100 may be inflatedfor deploying and tamponading the hemostat 1210 onto the tissue asdescribed above.

FIG. 32A shows the hemostat 1210 provided at the distal end 1104 of theinstrument 1100 and loaded within the cartridge 1192. Referring to FIG.32B, the loaded cartridge and the distal tip of the applicatorinstrument are then advanced toward the distal end of the outer tube1112 until the distal end of the cartridge engages the cartridge stopfeature 1235 provided at the distal end 1232 of the outer tube 1112.Referring to FIG. 32C, the instrument and the hemostat 1210 is thenfurther advanced distally so as to pierce the fluid-resistant seal 1200at the distal end of the cartridge 1192 for delivering the hemostat 1210to a target site.

The present invention may be used to deliver, deploy and tamponadehemostats and medical textiles such as meshes, hemostats, adhesionprevention barriers, sponges, Surgicel Interceed, and Surgicel Nu-Knit.The present invention may also be used for the delivery, deployment andtamponade of other topically applied hemostats (TAH). The presentinvention preferably includes applicator instruments that protect thehemostats from exposure to fluids and moisture until the hemostats aredeployed onto target tissue.

In one embodiment, the present invention provides an applicatorinstrument that includes an inflatable balloon that is used toendoscopically deploy and tamponade a textile or sponge form ofhemostat. In one embodiment, the deflated balloon is tubular and isattached at each end to one of two pieces of concentric tubing such thatone balloon end is movable and the balloon's shape is changeable fromspherical to toroidal. The balloon's attachment at its distal end issuch that the balloon is inverted over itself. When the balloon isinflated, the attachment of the distal end of the balloon to the distalend of the device is inside the inflated balloon.

In one embodiment, a cartridge has a fluid-resistant seal at the distalend thereof that protects the hemostats from moisture until thehemostats are applied to tissue. Barbed or Velcro®-like hooks may beincorporated at the distal end of the applicator instrument for engagingthe hemostats and/or loading the hemostats into a cartridge. In oneembodiment, the barbs or hooks preferably engage the fibers of thehemostat to hold the hemostat to the distal end of the instrument. Inone embodiment, a system may include an applicator instrument, multiplecartridges, and a cartridge loader for aligning hemostats such astopically applied hemostats with the cartridges.

In one embodiment, an applicator instrument and cartridge protectstopically applied hemostats from exposure to the environment such asexposure to moisture until the hemostat is applied to the target tissue.Preventing moisture from contacting the hemostat patch preventspremature activation of any medical components applied on the patch. Thepresent invention also prevents the loss of patches attached to thedistal end of an applicator instrument before the patches are applied tothe target tissue. This feature may be particularly important forhemostat patches that are relatively expensive such as hemostatsincluding human thrombin or fibrinogen.

In one embodiment, the present invention enables the shape of aninflated balloon to be changed so as to maximize the surface areaavailable for selectively applying tamponade pressure to a medicalpatch. Thus, the present invention enables an increased balloon surfacearea to be applied to a medical patch. This may be particularly usefulfor applying pressure on hemostatic dressings.

While the foregoing is directed to embodiments of the present invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof.

1. An instrument for controlling bleeding comprising: an intermediateshaft having a proximal end, a distal end, and a central lumen extendingto the distal end; an inner shaft telescopically received within thecentral lumen of said intermediate shaft, said inner shaft having aproximal end and a distal end that extends distally from said outershaft; a balloon having a proximal end secured to said intermediateshaft and a distal end secured to said inner shaft; a first actuator forinflating said balloon; and a second actuator for moving the distal endsof said intermediate and inner shafts relative to one another forchanging the shape of said balloon.
 2. The instrument as claimed inclaim 1, wherein the proximal end of said balloon is secured to thedistal end of said intermediate shaft and the distal end of said balloonis secured to the distal end of said inner shaft.
 3. The instrument asclaimed in claim 2, wherein the distal end of said balloon is invertedand the inverted distal end is secured to the distal end of said innershaft.
 4. The instrument as claimed in claim 1, wherein said balloon hasa spherical shape when said intermediate and inner shafts are in a firstposition and a toroidal shape when said intermediate and inner shaftsare in a second position.
 5. The instrument as claimed in claim 1,further comprising an outer shaft having a proximal end, a distal end,and a central lumen extending to the distal end thereof, wherein saidintermediate and inner shafts are disposed within the central lumen ofsaid outer shaft.
 6. The instrument as claimed in claim 5, wherein saidintermediate shaft extends distally from the distal end of said outershaft and is adapted to slide telescopically relative to said outershaft.
 7. The instrument as claimed in claim 6, further comprising athird actuator coupled with said outer shaft for moving the distal endof said outer shaft proximally relative to the distal ends of saidintermediate and inner shafts.
 8. The instrument as claimed in claim 8,further comprising a hemostat disposed at the distal end of said innershaft.
 9. The instrument as claimed in claim 8, wherein said hemostat isfolded over the distal end of said inner shaft.
 10. The instrument asclaimed in claim 9, further comprising barbs located at the distal endof said inner shaft for attaching said hemostat to said inner shaft. 11.The instrument as claimed in claim 8, further comprising afluid-resistant element covering said hemostat and being connected tothe distal end of said outer shaft, wherein said fluid-resistant elementincludes a breakable seal through which said hemostat is adapted topass.
 12. An instrument for controlling bleeding comprising: an outershaft having a proximal end, a distal end, and a central lumen extendingto the distal end thereof; an intermediate shaft telescopically receivedwithin the central lumen of said outer shaft, said intermediate shafthaving a proximal end, a distal end that extends distally from thedistal end of said outer shaft, and a central lumen extending to thedistal end thereof; an inner shaft telescopically received within thecentral lumen of said intermediate shaft, said inner shaft having aproximal end and a distal end that extends distally from saidintermediate shaft; a balloon having a proximal end secured to thedistal end of said intermediate shaft and a distal end that is invertedand secured to the distal end of said inner shaft; a fluid inlet locatedbetween the proximal and distal ends of said balloon for selectivelyinflating said balloon a hemostat disposed at the distal end of saidinner shaft; and at least one actuator for selectively moving the distalends of said intermediate and inner shafts relative to one another forchanging the shape of said balloon.
 13. The instrument as claimed inclaim 12, further comprising a fluid-resistant element covering saidhemostat, said fluid-resistant element being connected with the distalend of said outer shaft.
 14. The instrument as claimed in claim 13,wherein said fluid-resistant element comprises a breakablefluid-resistant seal through which said hemostat is adapted to pass. 15.The instrument as claimed in claim 12, wherein said at least oneactuator comprises: a first actuator coupled with said outer shaft forselectively moving said outer shaft proximally relative to the distalends of said intermediate and inner shafts; a second actuator forselectively inflating said balloon; and a third actuator coupled withone of said intermediate and inner shafts for selectively moving thedistal ends of said intermediate and inner shafts relative to oneanother.
 16. The instrument as claimed in claim 12, wherein saidintermediate and inner shafts have tubular shapes, and wherein at leastone of said intermediate and inner shafts has an opening for introducingfluid into said balloon.
 17. The instrument as claimed in claim 15,wherein said second actuator comprises: a plunger advanceable toward thedistal end of said outer shaft for introducing fluid into said balloon;and a locking ring adapted to selectively engage an outer surface ofsaid plunger for locking said plunger from movement.
 18. An instrumentfor controlling bleeding comprising: an outer shaft having a proximalend and a distal end; a balloon disposed at the distal end of said outershaft; a hemostat disposed adjacent said balloon; an actuator forinflating said balloon; and another actuator for changing the shape ofsaid inflated balloon.
 19. The instrument as claimed in claim 18,wherein said outer shaft has a central lumen extending to a distal endthereof, and wherein said instrument further comprises: an intermediateshaft telescopically received within the central lumen of said outershaft, said intermediate shaft having a proximal end, a distal end thatextends distally from the distal end of said outer shaft, and a centrallumen extending to the distal end thereof; an inner shaft telescopicallyreceived within the central lumen of said intermediate shaft, said innershaft having a proximal end and a distal end that extends distally fromsaid intermediate shaft; and said balloon having a proximal end securedto the distal end of said intermediate shaft and a distal end secured tothe distal end of said inner shaft.
 20. The instrument as claimed inclaim 18, further comprising a fluid-resistant seal covering saidhemostat and being coupled with the distal end of said outer shaft. 21.The instrument as claimed in claim 19, wherein said another actuator iscoupled with at least one of said intermediate and inner shafts formoving the distal ends of said intermediate and inner shafts relative toone another for changing the shape of said balloon.
 22. The instrumentas claimed in claim 21, wherein the distal ends of said intermediate andinner shafts are movable between a first position in which said balloonhas a spherical shape and a second position in which said balloon has atoroidal shape.
 23. The instrument as claimed in claim 19, wherein thedistal end of said balloon is inverted and secured to the distal end ofsaid inner shaft.
 24. The instrument as claimed in claim 19, furthercomprising a fluid inlet located between the proximal and distal ends ofsaid balloon for introducing fluid into said balloon.
 25. The instrumentas claimed in claim 19, further comprising a hemostat delivery actuatorcoupled with said outer shaft for selectively moving the distal end ofsaid outer shaft proximally relative to the distal ends of saidintermediate and inner shafts.